Duxet 60 mg. 28 tablets

1. What DUXET is and what it is used for

DUXET contains the active substance duloxetine. DUXET increases serotonin and norepinephrine levels in the nervous system.

DUXET is used in adults to treat:

depression;

generalized anxiety disorder (chronic feeling of anxiety or nervousness);

diabetic neuropathic pain (often described as burning, stabbing, tingling, shooting, or pain, or similar to an electric shock. There may be loss of sensation in an affected area, or sensations such as touch, heat, cold, or pressure may cause pain).

For most people with depression or anxiety, DUXET starts to work within two weeks of starting treatment, but it may take 2-4 weeks before you feel better. Tell your doctor if you do not start to feel better after this time. Your doctor may continue to give you DUXET when you feel better to prevent your depression or anxiety from returning.

For most people with diabetic neuropathic pain, it may take several weeks of treatment before you feel better. Tell your doctor if you do not feel better after 2 months.

2. What you need to know before you take DUXET

DO NOT take DUXET if:

you are allergic to duloxetine or any of the other ingredients of this medicine (listed in section 6);

you have liver disease;

you have severe kidney disease;

you are taking or have taken in the last 14 days another medicine known as a monoamine oxidase inhibitor (MAOI) (see "Taking other medicines")

you are taking fluvoxamine, which is usually used to treat depression, ciprofloxacin or enoxacin, which are usually used to treat certain infections;

you are taking other medicines containing duloxetine (see "Taking other medicines")

medicines such as Duxet (called serotonin and norepinephrine reuptake inhibitors) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms persist after treatment is stopped.

Tell your doctor if you have high blood pressure or heart disease. Your doctor will tell you if you should take DUXET.

Warnings and precautions

Talk to your doctor or pharmacist before taking DUXET if:

you are taking medicines to treat depression (see "Taking other medicines");

taking St. John's wort in herbal treatment (Hypericum perforatum);

you have kidney disease;

you have had fits (seizures);

you have had an obsession;

you suffer from bipolar disorder;

you have eye problems, such as certain types of glaucoma (increased pressure in the eye);

you have a history of bleeding disorders (tendency to bruise);

you are at risk of low sodium levels (for example, if you take diuretics, especially if you are elderly);

you are currently being treated with another medicine that may cause liver damage;

you are taking other medicines containing duloxetine (see "Taking other medicines").

DUXET may cause you to feel restless or unable to sit or stand still. You should tell your doctor if this happens to you.

Suicidal thoughts and worsening of your depression or anxiety disorder

If you are depressed and/or have an anxiety disorder, you may sometimes have thoughts of harming or killing yourself. These thoughts may become more common when you first start taking antidepressants, as all these drugs take time to work - usually about two weeks, but sometimes longer.

You may be more likely to think this way if:

you have previously had thoughts of suicide or self-harm

you are a young adult patient. Information from clinical trials indicates an increased risk of suicidal behavior in adults under 25 years of age with psychiatric conditions treated with an antidepressant

If you have thoughts of harming or killing yourself at any time, contact your doctor or go to hospital straight away.

You may find it helpful to tell a relative or close friend that you are depressed or have an anxiety disorder and ask them to read this leaflet. You can ask them to tell you if they think your depression or anxiety is getting worse, or if they are concerned about changes in your behaviour.

Children and adolescents

DUXET should not normally be used in children or adolescents under 18 years of age. Also, you should be aware that patients under 18 years of age are at increased risk of adverse effects such as suicidal thoughts and attempts and hostility (mainly aggression, oppositional behavior and anger) when using this class of drugs. However, your doctor may prescribe DUXET to a patient under 18 years of age and if you would like to discuss this please contact him. You should inform the doctor if any of the symptoms mentioned above occur or worsen when a patient under 18 years of age is taking DUXET. Axis

Other medicines and DUXET

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those obtained without a prescription.

The main ingredient in DUXET, duloxetine, is used in other medicines for other conditions:

diabetic neuropathic pain, depression, anxiety and urinary incontinence. The use of more than one of these drugs at the same time should be avoided.

Check with your doctor if you are already taking other medicines containing duloxetine.

Your doctor will decide if you can take DUXET with other medicines. Do not start or stop taking any medicine, including over-the-counter or herbal medicines, before talking to your doctor.

You should also tell your doctor if you are taking any of the following:

Monoamine oxidase inhibitors (MAOIs): you should not take DUXET if you are taking or have recently taken (within the last 14 days) another antidepressant medicine called a monoamine oxidase inhibitor (MAOI). Taking MAOIs with many prescription drugs, including DUXET, can cause serious or even life-threatening side effects. You must wait at least 14 days after you stop taking MAOIs before you can take DUXET. It is also necessary to wait at least 5 days after stopping taking DUXET before taking MAOIs.

Medicines that cause drowsiness: These include medicines prescribed by your doctor, including benzodiazepines, strong painkillers, antipsychotics, phenobarbital and antihistamines.

Drugs that increase serotonin: Triptans, tramadol, tryptophan, SSRIs (such as paroxetine and fluoxetine), tricyclic antidepressants (such as clomipramine, amitriptyline), pethidine, St. John's wort, and venlafaxine. These drugs increase the risk of side effects; if you experience any unusual symptoms while taking these medicines at the same time as DUXET, you should consult your doctor.

Oral anticoagulants or antiplatelets: Medicines that thin the blood or prevent the blood from clotting. These medicines can increase the risk of bleeding.

DUXET with food, drinks and alcohol

DUXET can be taken with or without food. Caution should be exercised if you consume alcohol while on DUXET treatment.

Pregnancy, lactation and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before using this medicine.

Tell your doctor if you become pregnant or plan to become pregnant while taking DUXET. Use DUXET only after discussing with your doctor the potential benefits and any possible risks to the unborn child.

Make sure your midwife and/or doctor know you are receiving DUXET. When such medicines (SSRIs) are taken during pregnancy, it can increase the risk of a serious condition in babies called persistent pulmonary hypertension of the newborn (PPHN), which causes the baby to breathe rapidly and appear bluish. These signs usually start within the first 24 hours after the baby is born. If this happens to your baby, you should contact your midwife and/or doctor immediately.

If you take DUXET towards the end of your pregnancy, your baby may have some signs when it is born. They usually start at birth or within a few days after your baby is born. These signs may include relaxed muscles, tremors, nervousness, not eating properly, difficulty breathing, and seizures. If your baby has any of these signs at birth, or you are concerned about their health, contact your doctor or midwife who will be able to advise you.

Tell your doctor if you are breast-feeding. It is not recommended to use DUXET during breastfeeding. You should consult your doctor or pharmacist.

Driving and using machines

Do not use any machinery or machinery until you know how DUXET will affect you.

DUXET contains sucrose

DUXET contains sucrose. If your doctor has told you that you have an intolerance to some sugars, consult him before taking this medicinal product.

3. How to take DUXET

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

DUXET is for oral use. You should swallow the capsule whole, with a glass of water.

For depression and diabetic neuropathic pain:

The usual dose of DUXET is one capsule (60 mg duloxetine) once a day, but your doctor will prescribe the dose that is right for you.

For generalized anxiety disorder:

The usual starting dose of DUXET is 30 mg once a day, after which most patients take 60 mg once a day, but your doctor will prescribe the right dose for you. The dose may be adjusted up to 120 mg per day based on the basis

If you have taken more than the required dose of DUXET

Contact your doctor or pharmacist immediately if you have taken more DUXET than prescribed by your doctor. Signs of overdose are drowsiness, coma, serotonin syndrome (a rare reaction that can lead to feelings of great happiness, sleepiness, clumsiness, restlessness, feeling intoxicated, fever, sweating or muscle stiffness), seizures, vomiting and a fast heart rate .

If you forget to take DUXET

If you miss a dose, take it as soon as you remember. In case it is time for your next dose, skip the missed dose and just take the single dose as usual. Do not take a double dose to make up for a missed dose. Do not take more than the daily amount of DUXET prescribed for you in one day.

If you have stopped taking DUXET

DO NOT stop taking your capsules without your doctor's advice, even if you feel better.

If your doctor considers that you no longer need DUXET, he/she will advise you to reduce your dose for at least 2 weeks before finally stopping treatment.

Some patients who stop taking DUXET suddenly have experienced symptoms such as:

dizziness, fatigue, sensations of numbness or sensations similar to the passage of an electric current (especially in the head area), sleep disorders (vivid dreams, nightmares, insomnia), fatigue, drowsiness, feeling of restlessness and agitation, feeling of anxiety, nausea or vomiting, shaking (tremor), headache, muscle pain, feeling irritable, diarrhoea, excessive sweating or dizziness.

These symptoms are usually not serious and disappear within a few days, but if you have symptoms that worry you, ask your doctor for advice.

If you have any further questions related to the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Very common side effects (may affect more than 1 in 10 people)

headache, feeling sleepy;

nausea (nausea), dry mouth.

Common side effects (may affect up to 1 in 10 people)

Lack of appetite;

sleep problems, feeling restless, decreased sex drive, anxiety, difficulty reaching or no orgasm, vivid dreams;

dizziness, feeling weak, tremors, tingling, goosebumps, or tingling in the skin;

blurred vision;

tinnitus (hearing ringing in the ears when there is no external sound source);

palpitations;

increased blood pressure, flushing;

more frequent yawning;

constipation, diarrhea, stomach pain, nausea (vomiting), heartburn or indigestion, gas;

increased sweating, (itchy) rash;

muscle pain, muscle spasm;

painful urination, frequent urination;

problems achieving an erection, changes in ejaculation;

seizures (mainly in elderly people), fatigue;

weight loss.

Children and adolescents under 18 years of age with depression who are treated with this medicine have little weight loss when they first start taking it. Weight increased to that of other children and adolescents of their age and gender after 6 months of treatment.

Uncommon side effects (may affect up to 1 in 100 people)

inflammation of the throat causing a hoarse voice;

suicidal thoughts, trouble sleeping, teeth grinding or clenching, feeling disoriented, lack of motivation;

sudden involuntary convulsions or twitching of the muscles, feeling restless or unable to sit or stand still, feeling nervous, difficulty concentrating, changes in the sense of taste, difficulty controlling movement eg lack of coordination or involuntary muscle movements, restless legs, bad sleep;

dilated pupils (the dark central part of the eye), vision problems;

feeling sleepy or "dizzy" (vertigo), pain in the ears;

fast and/or irregular heartbeat;

fainting, dizziness, blacking out or fainting when standing up, cold fingers and/or toes;

tightness in the throat, nosebleeds;

vomiting blood or tar-black stools (faeces), gastroenteritis, belching, difficulty swallowing;

inflammation of the liver, which can cause abdominal pain and yellowing of the skin or the whites of the eyes;

night sweats, rash, cold sweat, sensitivity to sunlight, increased tendency to bruise;

muscle tension, muscle twitching;

difficulty or inability to urinate, difficulty starting to urinate, need to urinate at night, need to urinate more often than usual, weak stream of urine;

unusual vaginal bleeding, irregular menstrual periods, including heavy, painful, irregular, or prolonged periods, unusually light or absent periods, pain in the testicles or scrotum;

5. How to store DUXET

Keep this medicine out of the reach of children.

Do not use this medicine after the expiry date which is stated on the carton.

Store in original packaging to protect from moisture. To be stored below 30°C.

Do not dispose of medicines down the drain or in the household waste container. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment.

6. Contents of the package and additional information

What DUXET contains

The active ingredient is duloxetine. Each capsule contains 60 mg of duloxetine as duloxetine hydrochloride.

The other ingredients are:

Capsule content: sugar spheres; hydroxypropylmethyl cellulose (such as HPMC 603 and HPMC-AS-LF); sucrose; talc; triethyl citrate; ammonium hydroxide (25% solution); titanium dioxide (E 171); opadri white 02A28361

Composition of opadry white 02A28361: titanium dioxide (E 171); HPMC 2910/ Hypromellose (E464); talc

Composition of the capsule shell: titanium dioxide (E 171); FD & C Blue 2 / Indigo Carmine (E 132); gelatin

What DUXET looks like and contents of the pack

Size "1" hard gelatin capsules with an opaque green body and an opaque blue cap, filled with white to off-white pellets.

Blister made of opaque PVC/PE/PVDC-Al foil

One blister contains 14 gastro-resistant hard capsules.

Package size: 28 gastro-resistant hard capsules (2 blisters)